KH
Validation Engineer
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- 20 hours ago
- GMP
20 hours ago
Not enough detail in this posting to match
Our client is seeking multiple Validation Engineers to support commissioning, qualification, and validation activities for a new manufacturing facility, including Process validation, cleaning validation and Computer system validation.
Roles & Responsibilities:
- The consultant will be responsible for developing and executing qualification protocols, supporting SATs, and performing cleaning validation and CSV activities across a variety of process equipment and manufacturing systems.
- Equipment may include filtration systems, filters, tanks, pumps, chromatography systems, bioreactors, and associated process equipment. Responsibilities will include preparing and executing IQ/OQ/PQ documentation as applicable, supporting equipment readiness and startup, reviewing technical documentation, and ensuring systems meet approved requirements and applicable GMP standards.
- The ideal candidate will have a strong background in equipment qualification and validation within pharmaceutical, biotechnology, or other regulated manufacturing environments.
- Experience with cleaning validation, computerized system validation, risk assessments, requirements traceability, deviation resolution, and validation documentation is highly desirable.
- The consultant will work closely with engineering, quality, automation, and equipment vendors to resolve deficiencies, maintain compliance, and support the successful startup of manufacturing operations.
Validation Engineer · Katalyst Healthcares & Life Sciences